FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 1812227
·
Received August 24, 2010
Report
- Report Number
- 3005477969-2010-00105
- Event Type
- Injury
- Date Received
- August 24, 2010
- Date of Event
- July 20, 2010
- Report Date
- February 18, 2011
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE REVISION SURGERY WAS PERFORMED DUE TO PAIN. BOTH THE ACETABULAR CUP AND FEMORAL HEAD WERE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BHR | RESURFACING FEMORAL HEAD | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. | 75661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| R | ACETABULAR CUP, PART#74120148 , LOT# 75565 |